Director, Global Regulatory Affairs

Protara Therapeutics, Inc. • New York, NY

1d • $228,000 - $233,000 • Hybrid

About The Position

The Director, Global Regulatory Affairs leads Protara’s ex-US regulatory strategy and operational execution for Protara’s clinical studies in oncology, cell and gene therapy, and rare diseases. The leader will possess ex-US global submissions experience and manage study specific regulatory submissions and will have country level experience either from the sponsor or CRO side managing global studies. The Director, Global Regulatory Affairs will provide leadership on ex-US regulatory activities for Protara’s product portfolio, and responsibility will focus on clinical study applications and provide regulatory leadership on the project teams in this area. The candidate will lead and/or supervise IND/CTA submissions including but not limited to South America, APAC, EU, etc.
This person must be able to work remotely or hybrid in the NYC office.

Requirements

• To be considered, you must possess excellent written and verbal communication skills along with an MD, Ph.D., or Pharm D. degree.
• We expect a minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.
• 8–12+ years of regulatory affairs experience in the biopharmaceutical industry.
• Demonstrated success interacting with the FDA, EMA and other global health authorities for oncology, cell and gene therapy, or rare disease programs.
• Hands‑on experience leading IND submissions and regulatory meetings.
• Strong understanding of CMC, nonclinical, and clinical requirements for advanced biologics.
• Excellent written and verbal communication skills, with the ability to translate complex science into clear regulatory positions.
• Must be proficient in MS Office Suite, with advanced skills in Excel.
• Strong interpersonal skills, including ability to communicate effectively with diverse audiences and build strong relationships
• Excellent written and oral communication and presentation skills.
• Ability to prioritize and multi-task successfully in a fast-paced environment.
• Excellent organizational skills and attention to detail are essential
• It is essential that this individual demonstrates the ability to work with highly confidential information.
• Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
• Strong analytical and problem-solving skills.
• Ability to work both independently and in a collaborative team setting.
• Proficiency in data mining/data extraction.
• Demonstrated experience working with and presenting to senior level management.
• Ability to work through uncertainty.

Nice To Haves

• Experience supporting BLA/MAA preparation or review.
• Familiarity with global regulatory frameworks (EMA, MHRA, PMDA, CDE).
• Background in rare disease natural history studies or patient focused drug development.
• Experience in a fast-paced biotech environment with first inhuman or first in class programs.
• Experience with NetSuite, Workday Adaptive and/or Smartsheet is a plus

Responsibilities

• Provide interpretation of regulatory authorities’ feedback, policies, and guidelines.
• Lead the development of study level regulatory strategic plans either directly in conjunction with program and study teams.
• Own the preparation of major clinical submissions required for regulatory approval.
• Work with program and study teams to resolve complex project issues.
• Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals.
• Responsible for quality and timeliness of IND/CTA submissions.
• Interact with other functions and partners, in the preparation, review, and completion of documents for regulatory submissions.
• Successfully plan, prioritize, supervise and/or conduct activities in close collaboration with leads from other areas.
• Assure compliance with regulations and with program and study team timelines.
• Provide interpersonal support and lead personnel.
• Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams
• Strong understanding of global (US and ex-US) pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Oversight of CROs in the management of ex-US CTAs/INDs towards clinical trial activations preferred
• High attention to detail; ability to coordinate and prioritize assigned projects according to company goals
• You bring strong interpersonal skills both written and verbally.

Benefits

• We offer a competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.
• Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
• Company-wide dedication to profoundly impacting patients’ lives.
• Amazing culture whereby our core values and behaviors are shared cross-functionally.
• Flexible working hours/schedule.
• Generous Paid Holidays and Unlimited PTO.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree